AQUEBOGUE, N.Y., Aug. 23, 2019 /PRNewswire/ -- Altaire Pharmaceuticals, Inc., announces today that it is correcting its 08.22.19 Announcement of a Voluntary Recall for Veterinary Ophthalmic drug products and lots, within expiry, identified below.
Corrections are being made only for the Vetropolycin and Puralube products as indicated below; all corrections are explained in the brackets following the corrected lot numbers enumerated herein. No corrections are required for the Vetropolycin HC products and lots identified in the 08.22.19 Notice of Recall.
Product Description: Vetropolycin Ophthalmic Ointment NDC Number: 17033-028-38 Package Size: 3.5 gm – Lot #:/ Exp. Date: 17245/RHG (08/19), 17246/RHH (08/19), 17265/RHQ (09/19), 17305/RJE (10/19), 17329/RKD (11/19), 17330/RKE (11/19), 17331/RKF (11/19),17382/RLJ (12/19), 17383/RLK (12/19), 18010/SAF (01/20), 18011/SAG (01/20), 18233/SIG (09/20), 18234/SIH (09/20), 18270/SKA (11/20), 18271/SKB (11/20), 18312/SLH (12/20), 18313/SLI (12/20), 19019/TAI (01/21), 19020/TAJ (01/21), 19024/TAL (01/21), 19067/TCE (03/21), 19097/TDA (04/21). [Revised to remove duplicate Vetropolycin lot numbers.]
Product Description: Vetropolycin HC Ophthalmic Ointment NDC Number: 17033-030-88 Package Size: 3.5 gm – Lot #:/ Exp. Date: 17243/RHF (08/19), 17324/RJQ (10/19), 17326/RKA (11/19), 17327/RKB (11/19), 17328/RKC (11/19), 17389/RLN (12/19), 18013/SAH (01/20), 18028/SAQ (01/20), 18039/SBD (02/20), 19118/TDK (04/21).
Product Description: Puralube Vet Ophthalmic Ointment NDC Number: 17033-211-38 Package Size: 3.5 gm – Lot #:/ Exp. Date: 17252/RHJ (08/19), 17387/RLL (12/20), 17310/RJH (10/20), 18041/SBE (02/21), 18142/SFD (06/21), 18183/SGG (07/21), 18202/SHF (08/21), 19027/TAM (01/22), 19042/TBF (02/22), 19043/TBG (02/22), 19044/TBH(02/22), 19063/TCB (03/22), 19064/TCC (03/22), 19068/TCF (03/22). [Revised to remove Vetropolycin lot numbers and identify Puralube lot numbers.]
The products are manufactured and labeled exclusively for Dechra Veterinary Products. Altaire ships the products only to Dechra Veterinary Products. The products are distributed by Dechra Veterinary Products.
Altaire has notified Dechra by e-mail of the corrections on August 23, 2019, with specific directions to recall all units of the impacted lots.
Dechra customers with questions regarding this recall can contact Dechra directly by calling 1-866-933-2472, or e-mailing firstname.lastname@example.org. Pet Owners should contact their veterinary care provider if they have any questions.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's Center for Veterinary Medicine (CVM) program by using FORM FDA 1932a "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report" as follows:
- Online: submit fillable form found at https://www.fda.gov/media/125072/download via email to CVM1932a@fda.hhs.gov
- Regular Mail: mail form available at www.fda.gov/MedWatch/getforms.htm to Center for Veterinary Medicine Food and Drug Administration HFV-1 7500 Standish Place Rockville, MD 20855.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.